Quality & Compliance

• Risk Assessment
• GxP and ISO Quality Management System Development & Implementation
• Lean Optimization
• Validation and Quality Master Planning
• Computer System Validation
• GMP/GDP/GCP/GLP Compliance Auditing
• Qualification & Validation
• Cleaning Validation
• Standard Operating Procedures (SOPs) Development, Implementation & Optimization
• Change Control and CAPA Process Optimizations
• Compliance Investigations
• Batch Records Review and Optimization
• GxP Training
• Supplier Qualification & Auditing
• Product Recall